Three important regulatory developments were published yesterday in the Federal Register by the Commerce Department’s Bureau of Industry and Security...more
With reports of widespread shortages of personal protective equipment (PPE) and ventilators and the COVID-19 pandemic continuing to expand nationwide, the Trump Administration has turned to the Defense Production Act (DPA) –...more
4/9/2020
/ Coronavirus/COVID-19 ,
Defense Production Act ,
Exports ,
Federal Contractors ,
FEMA ,
Imports ,
Manufacturers ,
Medical Devices ,
Medical Supplies ,
Personal Protective Equipment ,
Supply Chain
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time.
...more
3/25/2020
/ Adverse Events ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
EU ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Regulatory Oversight ,
REMS
As of 16 March 2020 Iran Air and a number of other entities were placed on the Bureau of Industry and Security's (BIS) Entity List.
Summary -
Companies that use Iran Air as transport, particularly companies engaging in...more
3/17/2020
/ Airlines ,
Aviation Industry ,
Bureau of Industry and Security (BIS) ,
Entity List ,
Export Administration Regulations (EAR) ,
Export Controls ,
Exports ,
Foreign Policy ,
General Licenses ,
Iran ,
National Security ,
Office of Foreign Assets Control (OFAC) ,
Prohibited Transactions
The EU has imposed restrictions on exports of certain personal protective equipment (PPE), whether originating or not in the European Union, in response to the COVID-19 outbreak....more
On 27 February 2020, the Office of Foreign Assets Controls (OFAC) issued General License (GL) 8 authorizing certain humanitarian trade transactions involving the Central Bank of Iran (CBI) that are otherwise prohibited under...more
3/6/2020
/ Banks ,
Commodities ,
Economic Sanctions ,
Food Supply ,
Foreign Relations ,
General Licenses ,
Global Terrorism Sanctions Regulations (GTSR) ,
Humanitarian Assistance ,
Iran ,
Iran Sanctions ,
ITSR ,
Medical Devices ,
Office of Foreign Assets Control (OFAC) ,
Regulatory Requirements ,
Reporting Requirements ,
SDN List ,
Securities and Exchange Commission (SEC) ,
Switzerland ,
Trade Agreements
A deeper dive into the president's FY2021 budget request for the U.S. Department of Commerce reveals new initiatives aimed at safeguarding technology.
- The National Telecommunications and Information Administration (NTIA)...more
2/28/2020
/ 5G Network ,
Artificial Intelligence ,
Bureau of Industry and Security (BIS) ,
China ,
Critical Infrastructure Sectors ,
Emerging Technologies ,
Export Controls ,
NIST ,
NTIA ,
Supply Chain ,
Telecommunications ,
Trump Administration ,
U.S. Commerce Department
On 24 February 2020 the Bureau of Industry and Security (BIS) of the U.S. Department of Commerce published a final rule amending the Export Administration Regulations (EAR) and imposing additional export licensing...more
2/28/2020
/ Aircraft ,
Biological-Weapons ,
Bureau of Industry and Security (BIS) ,
Export Administration Regulations (EAR) ,
Export Controls ,
Exports ,
Foreign Relations ,
Licensing Rules ,
National Security ,
Nuclear Weapons ,
Russia ,
Software ,
U.S. Commerce Department ,
Vessels ,
Yemen
The U.S. Department of Commerce's Bureau of Industry and Security (BIS) published an interim final rule on 6 January 2020 imposing licensing requirements on certain artificial intelligence software specially designed to...more
1/30/2020
/ Bureau of Industry and Security (BIS) ,
ECCNs ,
Export Administration Regulations (EAR) ,
Export Controls ,
Exports ,
Final Rules ,
Interim Final Rules (IFR) ,
Popular ,
Rulemaking Process ,
Software ,
U.S. Commerce Department
The National Security Commission on Artificial Intelligence (the “Commission”), established by the John S. McCain National Defense Authorization Act for Fiscal Year 2019, issued an interim report providing the Commission’s...more
On 6 January 2020, the State Department's Directorate of Defense Trade Controls (DDTC) issued new frequently asked questions (FAQs) regarding the registration and licensing requirements under the International Traffic in Arms...more
The long-anticipated foreign investment review regulations were released for public inspection on 13 January, 2020. The regulations, scheduled to appear in the Federal Register on 17 January, 2020, are in two Federal Register...more
On 10 January 2020, in response to missile attacks by the Iranian military targeting two U.S. bases in Iraq, the United States Department of the Treasury, Office of Foreign Assets Control (OFAC) designated a number of senior...more
1/14/2020
/ Blocked Person ,
Construction Project ,
Economic Sanctions ,
Executive Orders ,
Foreign Policy ,
Foreign Relations ,
Goods or Services ,
Iran ,
Iran Sanctions ,
Manufacturers ,
Mining ,
Office of Foreign Assets Control (OFAC) ,
Prohibited Transactions ,
SDN List ,
Textiles ,
Trump Administration
Two years after the release of the first draft of the Chinese Export Control Law (the Law) in 2017 (the 2017 Draft), on 28 December 2019, a revised draft was published on the website of the National People's Congress for...more
1/8/2020
/ China ,
De Minimus Quantity Exemption ,
Dual Use Goods ,
End-Users ,
Export Administration Regulations (EAR) ,
Export Controls ,
Exports ,
Licensing Rules ,
Military End Use ,
Military Goods ,
Policies and Procedures ,
Trade Policy ,
Use in Commerce
On 13 December 2019 the U.S. Department of Justice's (DOJ) National Security Division (NSD) announced the release of its long-anticipated and updated Export Control and Sanction Enforcement Policy for Business Organizations...more
12/19/2019
/ Department of Justice (DOJ) ,
Economic Sanctions ,
Enforcement Authority ,
Export Controls ,
FCPA Guidance ,
National Security ,
Policy Statement ,
Sanction Violations ,
Self-Reporting ,
Trade Relations ,
Willful Misconduct
The Committee on Foreign Investment in the United States (CFIUS or the committee), a U.S. government interagency committee that conducts national security reviews of foreign investments, has released its annual report for...more
On 26 November 2019 the U.S. Department of Commerce issued a long-awaited proposed rule (or draft regulations) to implement Executive Order 13873, "Securing the Information and Communications Technology and Services Supply...more
11/27/2019
/ Acquisitions ,
Critical Infrastructure Sectors ,
Foreign Adversaries ,
Imports ,
Proposed Rules ,
Risk Assessment ,
Risk Management ,
Secretary of Commerce ,
Supply Chain ,
Telecommunications ,
Trump Administration ,
U.S. Commerce Department
On 5 November 2019 the Office of Foreign Assets Control (OFAC) issued two new general licenses authorizing certain transactions involving the government of Venezuela (GOV) and certain individuals affiliated with the GOV,...more
On 25 October the U.S. Departments of the Treasury and State announced the establishment of a new channel for conducting due diligence on humanitarian trade with Iran.
Foreign governments and foreign financial institutions...more
11/8/2019
/ AML/CFT ,
Due Diligence ,
FinCEN ,
Foreign Financial Institutions (FFI) ,
Foreign Relations ,
Humanitarian Assistance ,
Iran ,
Iran Sanctions ,
Money Laundering ,
Office of Foreign Assets Control (OFAC) ,
Reporting Requirements ,
Trump Administration
Recent actions by the U.S. Department of State underscore the Trump administration's efforts to use a "whole of government" approach to address perceived national security threats posed by China.
While these actions do not...more
On 21 October 2019 the Bureau of Industry and Security (BIS) issued a final rule amending Cuba-related provisions in the Export Administration Regulations (EAR).
The new rule further restricts exports and reexports of...more
10/25/2019
/ Aerospace ,
Aircraft Sales ,
Airlines ,
Bureau of Industry and Security (BIS) ,
Cuba ,
Export Administration Regulations (EAR) ,
Export Controls ,
Exports ,
Infrastructure ,
Licensing Rules ,
Revenue ,
Sanctions ,
Telecommunications ,
Threshold Requirements ,
Trade Relations ,
Vessels
On 14 October, President Donald Trump issued Executive Order 13894, Blocking Property and Suspending Entry of Certain Persons Contributing to the Situation in Syria (EO).
...more
10/18/2019
/ Blocked Person ,
Economic Sanctions ,
Executive Orders ,
Foreign Financial Institutions (FFI) ,
Foreign Policy ,
Foreign Relations ,
General Licenses ,
Office of Foreign Assets Control (OFAC) ,
SDN List ,
Syria ,
Trump Administration ,
Turkey ,
Unauthorized Transactions
On 7 October 2019 the U.S. Department of Commerce's Bureau of Industry and Security (BIS) expanded the Entity List, restricting certain transactions with 28 Chinese entities.
...more
10/16/2019
/ Artificial Intelligence ,
Bureau of Industry and Security (BIS) ,
China ,
Doing Business ,
ECCNs ,
Economic Sanctions ,
Educational Institutions ,
Entity List ,
Export Administration Regulations (EAR) ,
Export Controls ,
Exports ,
Foreign Entities ,
Human Rights ,
Research and Development ,
Surveillance ,
Universities
On 3 October 2019, the Department of Energy (DOE) published a notice of proposed rulemaking regarding the imposition of civil penalties for violations of the Part 810 regulations (10 CFR Part 810), which control the export of...more
10/11/2019
/ Civil Monetary Penalty ,
Department of Energy (DOE) ,
Energy Policy ,
Enforcement Actions ,
Export Bans ,
Export Controls ,
Exports ,
NDAA ,
Part 810 ,
Regulatory Violations ,
Rulemaking Process
The U.S. Commerce Department's Bureau of Industry and Security (BIS) is extending the temporary general license (TGL) for Huawei until 18 November 2019, and adding additional Huawei companies to the Entity List....more